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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K913794
Device Name SIMPEX INC. SURGICAL DRESSING
Applicant
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Applicant Contact XI MEI
Correspondent
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Correspondent Contact XI MEI
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/23/1991
Decision Date 11/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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